Title: Phase Ib/II study of EPA-based EphA2 targeted therapy for patients with metastatic triple-negative inflammatory breast cancer
Principal Investigator: Naoto T. Ueno, MD, PhD, of University of Texas MD Anderson Cancer Center in Houston
Description: Researchers are conducting a phase 1b/2 study to test the safety and efficacy of icosapent ethyl plus dasatinib in patients with metastatic, inflammatory triple-negative breast cancer (TNBC).
During each 28-day treatment cycle, patients will receive icosapent ethyl orally twice daily and dasatinib orally once daily.
The primary outcome of phase 1b is the maximum tolerated dose. The primary outcome of phase 2 is the overall response rate. Secondary outcomes include the clinical benefit rate, progression-free survival, overall survival, and induction of tumor apoptosis.
To be eligible for this study, patients must be 18 years of age or older and have a histologically confirmed diagnosis of TNBC. They must have had or currently have a clinical diagnosis of inflammatory breast carcinoma. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by the National Cancer Institute.
ClinicalTrials.gov. Testing an omega-3 fatty acid-based anti-cancer therapy for patients with triple-negative inflammatory breast cancer that has spread to other parts of the body. NCT05198843. Accessed December 13, 2022.